A concept of biocontainment for GMP cell production applied in a public hospital

L. Mustapha 1,2, J-M. Dubaele2, L. Waselle1, L. Tissot1, F. Sadeghipour3, J-F. Brunet1 1 Cell production center, Lausanne University Hospital, Chemin des Croisettes 22, 1066 Epalinges, Suisse
2 Pharmacie Centrale, Centre Hospitalier Universitaire, avenue Rene Laennec, 80054 Amiens, France
3 Service of Pharmacy, Lausanne University Hospital, Rue du Bugnon 46, 1000 Lausanne, Suisse

Advanced therapy medicinal products (ATMP) including cell and gene therapy medicinal products and tissue-engineered product [1] face enormous translating challenges in order to produce new treatments for severe diseases. These challenges need a multidisciplinary approach from cell biology to human clinical trials by considering good manufacturing practices, regulatory affairs, risk and quality assessments.

To ensure safety and high quality of ATMP, appropriate GMP production management and quality control are essential in a dedicated structure. The context of a public university hospital facilitates links between academic research and human clinical trials to offer great possibilities for innovation in the field.

To continue productions of autologous skin cells and develop new therapeutic tools in orthopedics and clinical neurosciences in our institution, Cell Production Center to encounter GMP rules has been built to obtain National agency authorization. To limit the risk of contamination and expensive costs, the concept of biocontainment was put in place by implementing isolators computerized production monitoring and quality control activities. Isolators allow all manipulations for GMP cell production: seeding, media change, growing, microscopy observations and harvest. The computerized monitoring ensures the traceability of all the activities from raw materials data to final product information including physical parameters. Through training and qualification of specialized personnel, our accredited GMP facility offers the possibility to develop new clinical trials such as cartilage repair or neurorehabilitation.

For the future and the professionalization of ATMP production, sharing of competencies and expertise between this type of facilities and hospital pharmacy experiences would facilitate personalized medicine treatment.

[1The European Parliament and the Council of the European Union Regulation (EC) No. 1394/2007 of the European Parliament and the Council of 13 November 2007 on Advanced Therapy Medicinal Products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union 10.12.2007;L324:121-137

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